A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer
A Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, Compared to Standard of Care in Subjects With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer After Progression on a Third-Generation EGFR TKI - AndroMETa-Lung-713
2 other identifiers
interventional
490
18 countries
109
Brief Summary
Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to assess adverse events and change in disease activity of telisotuzumab adizutecan as a monotherapy or in combination with osimertinib compared to standard of care (SOC). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. This study will be divided into two stages, in the first stage (phase 2) participants will receive 1 of 2 doses of telisotuzumab adizutecan as a monotherapy or in combination with osimertinib. In the second stage (phase 3) participants will receive the recommended phase 3 dose (RP3D) of telisotuzumab adizutecan, from the previous stage, or SOC. Approximately 490 adult participants with NSCLC will be enrolled in the study in 200 sites around the world. In phase 2, participants will receive 1 of 2 intravenous (IV) doses of telisotuzumab adizutecan as a monotherapy or in combination with oral osimertinib. In phase 3, participants will receive the IV RP3D of telisotuzumab adizutecan, or SOC. The study will run for a duration of approximately 69 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
Started Dec 2025
Typical duration for phase_2 nonsmall-cell-lung-cancer
109 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2025
CompletedFirst Posted
Study publicly available on registry
September 4, 2025
CompletedStudy Start
First participant enrolled
December 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2030
July 9, 2026
July 1, 2026
4.7 years
August 28, 2025
July 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Phase 2: Objective Response (OR) Assessed by the Blinded Independent Central Review (BICR)
OR is defined as participants achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) per the BICR based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Up to Approximately 69 Months
Phase 3: Progression-Free Survival (PFS) as assessed by the BICR
PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by the BICR or death from any cause, whichever occurs earlier.
Up to Approximately 69 Months
Secondary Outcomes (8)
Phase 2 and 3: Overall Survival (OS)
Up to Approximately 69 Months
Phase 2: PFS as assessed by the BICR
Up to Approximately 69 Months
Phase 2 and 3: Duration of Response (DoR) as Assessed by the BICR per RECIST v1.1
Up to Approximately 69 Months
Phase 2 and 3: Disease Control (DC) as Assessed by the BICR per RECIST v1.1
Up to Approximately 69 Months
Phase 3: OR Assessed by the BICR
Up to Approximately 69 Months
- +3 more secondary outcomes
Study Arms (6)
Phase 2: Telisotuzumab Adizutecan Dose A
EXPERIMENTALParticipants will receive telisotuzumab adizutecan dose A, as part of the approximately 69 month study duration.
Phase 2: Telisotuzumab Adizutecan Dose B
EXPERIMENTALParticipants will receive telisotuzumab adizutecan dose B, as part of the approximately 69 month study duration.
Phase 2: Telisotuzumab Adizutecan Dose A + Osimertinib
EXPERIMENTALParticipants will receive telisotuzumab adizutecan dose A in combination with osimertinib, as part of the approximately 69 month study duration.
Phase 2: Telisotuzumab Adizutecan Dose B + Osimertinib
EXPERIMENTALParticipants will receive telisotuzumab adizutecan dose B in combination with osimertinib, as part of the approximately 69 month study duration.
Phase 3: Telisotuzumab Adizutecan Recommended Phase 3 Dose
EXPERIMENTALParticipants will receive telisotuzumab adizutecan at the recommended phase 3 dose, as part of the approximately 69 month study duration.
Phase 3: Stand of Care (SOC)
EXPERIMENTALParticipants will receive investigator's choice of SOC, as part of the approximately 69 month study duration.
Interventions
Intravenous (IV) Infusion
Oral
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed diagnosis of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with documented EGFR Exon 19 deletion or Exon21 L858R mutation.
- Provide recently obtained tumor tissue during Screening for c-Met immunohistochemistry (IHC) testing (and study stratification in Phase 2). If recently obtained tumor tissue is not available, archived tumor tissue is also acceptable.
- Received one prior third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy in the adjuvant, locally advanced, or metastatic setting, either as monotherapy or in combination with other agents, and experienced documented radiographic disease progression on or after therapy for the most recent regimen administered prior to study entry. Participant who has received prior third-generation EGFR TKI therapy in the adjuvant setting must have progressed while on treatment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
- At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated.
You may not qualify if:
- Tumor(s) have adenosquamous or squamous histology or sarcomatoid features.
- Received more than 1 line of systemic therapy in the locally advanced or metastatic setting.
- Active/symptomatic central nervous system (CNS) metastases. Previously treated brain metastases may be included provided they are radiologically stable.
- Evidence of active interstitial lung disease (ILD)/pneumonitis or history of ILD or pneumonitis that required steroids.
- Have any clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (110)
Highlands Oncology Group - Springdale /ID# 277132
Springdale, Arkansas, 72762, United States
City of Hope National Medical Center /ID# 277005
Duarte, California, 91010, United States
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 277928
Irvine, California, 92618, United States
Cancer Specialists of North Florida /ID# 277332
Jacksonville, Florida, 32256, United States
Cancer Care Centers of Brevard- Rockledge /ID# 277853
Rockledge, Florida, 32955, United States
Moffitt Cancer Center /ID# 276785
Tampa, Florida, 33612, United States
Parkview Research Center /ID# 277651
Fort Wayne, Indiana, 46845, United States
HealthPartners Cancer Research Center /ID# 277339
Saint Louis Park, Minnesota, 55426, United States
Nho - Revive Research Institute /ID# 277569
Lincoln, Nebraska, 68506, United States
Dartmouth-Hitchcock Medical Center /ID# 277673
Lebanon, New Hampshire, 03756, United States
Astera Cancer Care /ID# 277570
East Brunswick, New Jersey, 08816-4096, United States
Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road /ID# 277891
Knoxville, Tennessee, 37909, United States
SCRI Oncology Partners /ID# 276959
Nashville, Tennessee, 37203, United States
Fred Hutchinson Cancer Center. /ID# 277939
Seattle, Washington, 98109-4405, United States
Northwest Cancer Specialists - Vancouver /ID# 277855
Vancouver, Washington, 98684, United States
Canberra Hospital /ID# 277166
Garran, Australian Capital Territory, 2605, Australia
St George Hospital - Kogarah /ID# 277168
Kogarah, New South Wales, 2217, Australia
Mater Hospital Brisbane /ID# 276985
South Brisbane, Queensland, 4101, Australia
Icon Cancer Centre Hobart /ID# 277549
Hobart, Tasmania, 7000, Australia
St Vincent's Hospital Melbourne /ID# 277002
Fitzroy, Victoria, 03065, Australia
Sunshine Hospital /ID# 276894
St Albans, Victoria, 3021, Australia
One Clinical Research - Nedlands /ID# 277598
Nedlands, Western Australia, 6009, Australia
Klinik Floridsdorf /ID# 276679
Vienna, State of Vienna, 1210, Austria
Institut Jules Bordet /ID# 277283
Anderlecht, Brussels Capital, 1070, Belgium
Grand Hopital de Charleroi - Les Viviers /ID# 277282
Charleroi, Hainaut, 6280, Belgium
Groupe Sante CHC - Clinique du MontLegia /ID# 278951
Liège, Liege, 4000, Belgium
Jessa Ziekenhuis - Campus Virga Jesse /ID# 277202
Hasselt, Limburg, 3500, Belgium
Universitair Ziekenhuis Leuven /ID# 276874
Leuven, Vlaams-Brabant, 3000, Belgium
Guangdong Provincial People's Hospital /ID# 277631
Guangzhou, Guangdong, 510080, China
The First affiliated hospital of Nanchang University (Xianghu campus) /ID# 277491
Nanchang, Jiangxi, 330209, China
Shanghai Pulmonary Hospital /ID# 277488
Shanghai, Shanghai Municipality, 200433, China
Xinjiang Medical University Cancer Hospital - Urumqi /ID# 277638
Ürümqi, Xinjiang, 830000, China
CHU Brest - Hopital de la Cavale Blanche /ID# 277883
Brest, Finistere, 29200, France
CHU de Lille - Institut Coeur Poumon /ID# 276868
Lille, Hauts-de-France, 59000, France
Hopital Arnaud de Villeneuve /ID# 276872
Montpellier, Herault, 34090, France
Institut Curie /ID# 277623
Paris, Île-de-France Region, 75248, France
Universitaetsklinikum Heidelberg /ID# 277275
Heidelberg, Baden-Wurttemberg, 69120, Germany
Universitaetsklinikum Wuerzburg /ID# 277213
Würzburg, Bavaria, 97080, Germany
Universitaetsklinikum Giessen und Marburg GmbH /ID# 276873
Marburg, Hesse, 35043, Germany
Universitaetsklinikum Koeln /ID# 276862
Cologne, North Rhine-Westphalia, 50937, Germany
Universitätsklinikum Jena /ID# 277281
Jena, Thuringia, 07747, Germany
Universitaetsklinikum Hamburg-Eppendorf /ID# 276869
Hamburg, 20246, Germany
Meir Medical Center /ID# 277289
Kefar Sava, Central District, 4428164, Israel
Rabin Medical Center /ID# 276748
Petah Tikva, Central District, 4941492, Israel
Yitzhak Shamir Medical Center /ID# 276750
Ẕerifin, Central District, 7030000, Israel
The Chaim Sheba Medical Center /ID# 276745
Ramat Gan, Tel Aviv, 5265601, Israel
Rambam Health Care Campus- Haifa /ID# 276746
Haifa, 3109601, Israel
Istituto Europeo Di Oncologia /ID# 276788
Milan, Milano, 20141, Italy
AST Pesaro Urbino - Presidio Ospedaliero Santa Croce Di Fano /ID# 277338
Fano, Pesaro E Urbino, 61032, Italy
Centro Di Riferimento Oncologico /ID# 276923
Aviano, Pordenone, 33081, Italy
IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 277296
Rome, Roma, 00144, Italy
Ospedale Isola Tiberina - Gemelli Isola /ID# 277117
Rome, Roma, 00186, Italy
Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 277119
Candiolo, Torino, 10060, Italy
AOU Policlinico G. Rodolico - San Marco /ID# 277265
Catania, 95123, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento /ID# 277280
Verona, 37126, Italy
Hokkaido University Hospital /ID# 277240
Sapporo, Hokkaido, 060-8648, Japan
Kitasato University Hospital /ID# 277241
Sagamihara-shi, Kanagawa, 252-0375, Japan
National Cancer Center Hospital /ID# 277093
Chuo-Ku, Tokyo, 104-0045, Japan
Wakayama Medical University Hospital /ID# 277238
Wakayama, Wakayama, 641-8510, Japan
Radboudumc /ID# 277639
Nijmegen, Gelderland, 6525 GA, Netherlands
Leids Universitair Medisch Centrum /ID# 277270
Leiden, South Holland, 2333 ZA, Netherlands
Erasmus Medisch Centrum /ID# 276989
Rotterdam, South Holland, 3015 CE, Netherlands
Universitair Medisch Centrum Utrecht /ID# 277114
Utrecht, 3584 CX, Netherlands
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeyla /ID# 277066
Poznan, Greater Poland Voivodeship, 60-569, Poland
Pratia MCM Krakow /ID# 277118
Krakow, Lesser Poland Voivodeship, 30-727, Poland
Provita Centrum Medyczne /ID# 277494
Warsaw, Masovian Voivodeship, 00-585, Poland
Uniwersyteckie Centrum Kliniczne /ID# 277210
Gdansk, Pomeranian Voivodeship, 80-214, Poland
Gyncentrum Sp. z o.o. /ID# 277522
Sosnowiec, Silesian Voivodeship, 41-208, Poland
Unidade Local de Saude do Alto Ave, EPE /ID# 277249
Guimarães, Braga District, 4835-044, Portugal
Unidade Local de Saude de Loures-Odivelas /ID# 277223
Loures, Lisbon District, 2674-514, Portugal
Unidade Local de Saude de Matosinhos EPE /ID# 277228
Senhora da Hora, Porto District, 4464-513, Portugal
Unidade Local de Saude de Braga, EPE /ID# 277217
Braga, 4710-243, Portugal
Unidade Local de Saude de Santo Antonio /ID# 277216
Porto, 4099-003, Portugal
Hospital Cuf Porto /ID# 277225
Porto, 4100-180, Portugal
University Clinical Center Serbia /ID# 277051
Belgrade, Beograd, 11000, Serbia
Clinical Hospital Center - Bežanijska Kosa /ID# 277052
Belgrade, Beograd, 11080, Serbia
University Clinical Center Nis /ID# 277200
Niš, Nisavski Okrug, 18300, Serbia
Institute For Pulmonary Diseases Of Vojvodina /ID# 277047
Kamenitz, Sremski Okrug, 21208, Serbia
University Clinical Center Kragujevac /ID# 277162
Kragujevac, Sumadijski Okrug, 34000, Serbia
National Cancer Center /ID# 277353
Goyang-si, Gyeonggido, 10408, South Korea
Chungbuk National University Hospital /ID# 277372
Cheongju-si, North Chungcheong, 28644, South Korea
Seoul National University Hospital /ID# 277373
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Yonsei University Health System Severance Hospital /ID# 277394
Seoul, Seoul Teugbyeolsi, 03722, South Korea
Asan Medical Center /ID# 277371
Seoul, Seoul Teugbyeolsi, 05505, South Korea
Samsung Medical Center /ID# 277600
Seoul, Seoul Teugbyeolsi, 06351, South Korea
Complejo Hospitalario Universitario de Santiago /ID# 277173
Santiago de Compostela, A Coruna, 15706, Spain
Hospital Universitari Parc Tauli /ID# 277177
Sabadell, Barcelona, 08208, Spain
Hospital Universitari Vall d Hebron /ID# 277156
Barcelona, 08035, Spain
Hospital Universitario Ramon y Cajal /ID# 277153
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre /ID# 277155
Madrid, 28041, Spain
Hospital Universitario Virgen de la Victoria /ID# 277159
Málaga, 29010, Spain
Hospital Clinico Universitario de Valencia /ID# 277147
Valencia, 46010, Spain
Hospital Clinico Universitario Lozano Blesa /ID# 277154
Zaragoza, 50009, Spain
Changhua Christian Hospital /ID# 277145
Changhua, 500, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 277138
Kaohsiung City, 807, Taiwan
Kaohsiung Chang Gung Memorial Hospital /ID# 277472
Kaohsiung City, 833, Taiwan
Taichung Veterans General Hospital /ID# 277142
Taichung, 407, Taiwan
Mackay Memorial Hospital /ID# 277146
Taipei, 104, Taiwan
National Taiwan University Cancer Center (Ntucc) /ID# 277134
Taipei, 106, Taiwan
Taipei Veterans General Hospital /ID# 277141
Taipei, 112, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 277135
Taoyuan City, 333, Taiwan
Sakarya Universitesi Tip Fakultesi - Korucuk Kampusu /ID# 276962
Adapazarı, Sakarya, 54290, Turkey (Türkiye)
Adana Sehir Hastanesi /ID# 276957
Adana, 01370, Turkey (Türkiye)
Gazi University Medical Faculty /ID# 276943
Ankara, 06560, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi /ID# 276961
Ankara, 06620, Turkey (Türkiye)
Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi /ID# 276956
Istanbul, 34722, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 277063
Istanbul, 34899, Turkey (Türkiye)
Samsun Medical Park Hastanesi /ID# 277201
Samsun, 55200, Turkey (Türkiye)
St Bartholomews Hospital - Barts Health /ID# 277301
London, Greater London, EC1A 7BE, United Kingdom
The Christie NHS Foundation Trust - Christie Hospital /ID# 277304
Manchester, M20 4BX, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2025
First Posted
September 4, 2025
Study Start
December 10, 2025
Primary Completion (Estimated)
September 1, 2030
Study Completion (Estimated)
September 1, 2030
Last Updated
July 9, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.